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Total Temporomandibular Joint Replacement System- 45mm Rt… recallZ-0512-2015 · Biomet Microfixation, LLC · initiated Oct 17, 2014

Class II Terminated All recalls posted in December 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet Microfixation, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Laser etching on the parts is wider and deeper than the conditions previously validated.

FDA root cause category: Software Design Change

What the company is doing

BIOMET sent an Urgent Medical Device Recall letter dated October 17, 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following steps: 1) Immediately locate and remove from circulation the items invoiced/consigned/loaned to your account. 2) Carefully follow the instructions on the enclosed "Response Form." and 3)If you have further distributed these items to medical facilities, you must notify them of this action. For questions customers were instructed to call 1-800-874-7711 or 904-741-4400, extension 9448, Monday through Friday, 8 a.m. to 4 p.m. EST. For questions regarding this recall call 904-741-9448.

Recall details

Recall number
Z-0512-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 17, 2014
Posted by the FDA
Dec 16, 2014
Recalling firm
Biomet Microfixation, LLC
Quantity
42
Product code
LZD
FDA submissions
P020016
Distribution
Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.

Product description

Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint

Code information (models, lots, serial numbers)

Model 24-6645TI, Lot #s: 472580A, 472590B, 472580B, 472590A, 526030A, 526020A, 526020B, 526030B.

Other devices under the same FDA submission

30 devices cleared under P020016 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 69644).

Sources and updates

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